BioPharma R&D Flashcards
What are the phases of Biopharma R&D?
- Discovery and Development
- Pre-clinical research
- Clinical Research
What is Discovery and Development trying to answer?
- What is the therapeutic area/condition to be treated?
- What is the target confidence
What is Pre-Clinical Research trying to answer?
- What modality/approach to use
- Are screening tools in place?
- Translational assay to improve clinical success?
How long does the Clinical Research Phase take?
9 years (-3 years with accelerated approval)
What is Clinical Research trying to answer?
- Are clinical biomarkers available?
- Target engagement?
What is target engagement accomplishing?
Efficacy with safety: Does the medicine safely work?
What is the most important factor for why drug development fails, and what are the other reasons?
Lack of clinical efficacy
(also unmanageable toxicity, poor drug-like properties, lack of commercial need/poor strategic planning)
How much does it cost to bring a new drug to the market?
$1.1 billion
What is the overall likelihood of approval from Phase 1 onward?
8%
Why do people still go into oncology despite ophthalmology having a higher success rate?
More people get cancer (more immediate need)
What are the 2 big factors affecting clinical development times, and which is the fastest of each category?
Therapeutic class (Antiviral = 7yrs)
Modality (oligonucleotide = 6yrs)
Rank the approaches (in cancer) from most to least successful:
Small molecules, antibodies, others
Antibodies > small molecules > > others
Rank the % approval of the following clinical trials from smallest to largest, and give the % approval in Ph1 and Ph2 of each:
Ophthalmology, CNS, Oncology
Oncology (Ph1=3%, Ph2=7%) < CNS (Ph1=15%, Ph2=20%) < Opthalmology (Ph1=33%, Ph2=34%)
